2021 ESC 主動脈和外周動脈疾病的抗栓治療共識（一）

Victor Aboyans^1*、Rupert Bauersachs²、Lucia Mazzolai³、Marianne Brodmann⁴、José F.Rodriguez Palomares⁵、Sebastian Debus⁶、Jean-Philippe Collet⁷、Heinz Drexel⁸、Christine Espinola-Klein⁹、BasilS.Lewis¹⁰、Marco Roffi¹¹、Dirk Sibbing¹²、Henrik Sillesen^13,14、Eugenio Stabile¹⁵、Oliver Schlager¹⁶、和MarcoDeCarlo¹⁷

1.Department of Cardiology, Dupuytren University Hospital, and INSERM 1094 & IRD, University of Limoges, 2, Martin Luther King ave, 87042, Limoges, France;

2. Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt Germany, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz, Germany;

3. Division of Angiology,Heart and Vessel Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland;

4. Division of Angiology, Medical University Graz, Austria;

5. Department ofCardiology, Vall d’Hebron Institut de Recerca (VHIR), Hospital Universitari Vall d’Hebron, Universitat Auto`noma de Barcelona, Centro de Investigacio´n Biome´dica en RedCV, CIBER CV, Barcelona, Spain;

6. Department of Vascular Medicine, University Heart Centre Hamburg, University Medical Centre HamburgEppendorf, Hamburg, Germany;

7. Sorbonne Universite´, ACTION Study Group (www.actioncoeur.org), INSERM UMRS 1166, Institut de Cardiologie, Hoˆ pital Pitie´Salpeˆtrie`re (APHP), Paris, France;

8. Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Landeskrankenhaus Feldkirch, Austria;

9. Section Angiology, Department of Cardiology, Cardiology I, University Medical Center Mainz, Mainz, Germany;

10. Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, TechnionIsrael Institute of Technology, Haifa, Israel;

11. Division of Cardiology, University Hospitals, Geneva, Switzerland;

12. Ludwig Maximilians Universita¨t Mu¨nchen and Privatklinik Lauterbacher Mu¨hle am Ostersee, Munich,

Germany;

13. Department of Vascular Surgery, Rigshospitalet, University of Copenhagen, Denmark;

14. Department of Clinical Medicine, University of Copenhagen, Denmark;

15. Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples 'Federico II’, Naples, Italy;

16. Division of Angiology, 2nd Department of Medicine, Medical University of Vienna, Austria;

17. Cardiothoracic and Vascular Department, Azienda OspedalieroUniversitaria Pisana, Pisa, Italy

外周動脈疾病患者的最佳和替代性抗血栓策略摘要。^a在沒有任何其他血管疾病情況下。^b在小劑量阿司匹林和利伐沙班基礎上加用氯吡格雷可在考慮支架類型和長度、疾病嚴重程度和出血風險情況下根據具體病例決定。如加用氯吡格雷，則應限制在1個月内，以減少出血并發症。^{100 c}目前尚無直接比較R A與A C策略的數據。後者已經依靠經驗進行實施并被推薦用于血管内治療，¹而最近的一項随機試驗對R A進行了評估。⁸⁰此外，R A策略還可延長至血管重建後期，對MACE和MALE均有好處。

關鍵詞

抗血栓治療·抗凝血劑·抗血小闆藥物·外周動脈疾病·主動脈·下肢動脈疾病·頸動脈·椎動脈·鎖骨下動脈·腎動脈·腸系膜動脈·血栓形成

引言

2017年，歐洲心髒病學會（ESC）與歐洲血管外科學會合作發布了外周動脈疾病（PAD）診斷和處理指南。¹該文件強調了抗血栓治療對于預防主要不良心血管事件（MACE）的重要性，并強調了新型抗血栓治療相關風險降低方面的主要證據空白。自此開始，主要随機對照試驗（RCT）和注冊的結果讓這類患者的抗血栓方案發生極大的變化。此外，經常被歸類為主要不良肢體事件（MALE）的外周事件也日益受到關注。為此，參與編撰本合作文件的三個工作組意識到為臨床醫生提供整體路線圖的迫切需要，以便優化主動脈疾病和/或PAD患者的抗血栓治療，同時重點關注此類疾病的術後和慢性階段。本文件按動脈區域編撰，最後以因相關疾病需要長期口服抗凝血劑患者的處理以及血管患者的出血風險評估作為結束。

頸動脈、椎動脈和鎖骨下動脈

信息要點：頸動脈、鎖骨下動脈或椎動脈疾病的抗血栓治療

·對于有症狀或無症狀頸動脈狹窄患者，建議使用阿司匹林或氯吡格雷進行長期抗血小闆治療。

·雙聯抗血小闆治療（DAPT）（阿司匹林 替格瑞洛或氯吡格雷）可推薦用于輕度卒中或短暫性腦缺血發作（TIA）早期的有症狀頸動脈狹窄患者。

·DAPT（阿司匹林 氯吡格雷）推薦用于接受頸動脈支架置入術的患者，至少使用1個月。

·計劃接受CEA的患者應維持SAPT。

·對于無症狀頸動脈狹窄患者或有頸部血管重建史的患者，如果其因相關并發症（尤其是多血管患者）被認為具有極高風險并且出血風險不高，可建議長期低劑量利伐沙班聯合阿司匹林治療。^*

·在缺乏具體證據情況下，對于椎動脈和鎖骨下動脈疾病采用與頸動脈疾病相同的抗血栓策略具有合理性。

* 禁忌用于：顱内出血或缺血性卒中病史、其他顱内病理史、近期胃腸出血或可能因胃腸道失血引起的貧血、與出血風險增加相關的其他胃腸道病理、肝功能衰竭、出血性素質或凝血障礙，極高齡或脆弱，或存在需要透析或eGFR<15mL/min/1.73m²的腎功能衰竭。

頸動脈疾病的抗血栓治療

頸動脈斑塊是發生栓塞性卒中的潛在原因，并且其與卒中以外的心血管事件風險增加存在相關性。由于目前尚無研究單一抗血小闆治療（SAPT，如阿司匹林）減少非狹窄頸動脈斑塊患者心血管事件的相關試驗，因此本文件将側重于頸動脈狹窄（管腔狹窄>50%）的患者。

無症狀頸動脈疾病

無症狀頸動脈狹窄患者的抗血栓治療仍然存在争議。作為該背景下的唯一試驗，ACB研究未能顯示阿司匹林與安慰劑相比的優效性，但其規模有限（表1）。³ 在觀察性研究中，主要由低劑量阿司匹林構成的SAPT與MACE風險降低存在相關性，但中度狹窄（即50%–75%）的數據相互矛盾。^12–14DAPT聯合阿司匹林和氯吡格雷與SAPT相比沒有優勢。¹⁵ ESC指南建議對無症狀且≥50%頸動脈狹窄的患者（如果患者出血風險較低）進行長期SAPT。¹

最近，COMPASS試驗将慢性冠狀動脈和/或外周動脈疾病患者随機分為三組：雙通路抑制（DPI）聯合阿司匹林100 mg o.d. 利伐沙班2.5 mg bid對比利伐沙班5 mg bid對比阿司匹林100 mg o.d.。¹⁶總體而言，與單用阿司匹林的患者相比，分配使用DPI患者的MACE顯著下降（表1），在1919例有頸動脈血管重建史或無症狀≥50%狹窄的患者中觀察到類似的趨勢，盡管由于樣本量有限可能沒有統計學意義。¹⁶沒有報告無症狀頸動脈狹窄亞組的具體數據。

有症狀頸動脈疾病

有症狀頸動脈狹窄與腦血管缺血事件早期複發的高風險存在相關性。¹⁷在與大動脈疾病相關的腦血管意外患者中，SAPT（阿司匹林或氯吡格雷）在減少複發事件方面比口服維生素K拮抗劑（VKA）更為有效。^2,3,18,19SOCRATES試驗的同側動脈粥樣硬化性狹窄亞組分析表明，與接受阿司匹林的患者相比，接受替格瑞洛患者的MACE發生率顯著降低（表1）。⁴

對于有症狀頸動脈狹窄早期的DAPT，阿司匹林和氯吡格雷的合并用藥降低了無症狀腦栓塞和卒中的風險。^20–23另外其還降低了輕微卒中缺血性發作和TIA後卒中複發的風險。^24，25最近，在輕微卒中或高風險TIA患者中使用替卡格雷t阿司匹林與單用阿司匹林對照的THALES試驗（n=11 016）表明死亡或卒中風險顯著降低17％。²⁶在針對同側顱外/顱内狹窄>30%患者進行的預先指定亞組分析中，風險降低更加顯著（表1），并且具有非常高的收益/風險比。⁵有關雙嘧達莫減少卒中療效的數據存在不一緻，沒有針對頸動脈狹窄的特異性結果。^27–29

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